Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- PSA Test Device
- Model numbers
- EAN: 616612787316, SKU: G670D, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
The PSA Test device is used to measure prostate-specific antigen levels, typically as part of health assessments for men. It is distributed through healthcare settings.
Why This Is Dangerous
The defect relates to regulatory approval. If the device is not PMA-cleared, its safety and efficacy have not been formally evaluated by regulators.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Clinicians and patients may need to discontinue use and rely on alternative testing methods. The recall could affect ongoing diagnostic processes and scheduling.
Practical Guidance
How to identify if yours is affected
- Check model identifiers: EAN 616612787316 and SKU G670D
- Look for Lot/Serial Number across all lots
- Verify that the device is the PSA Test from GET TESTED INTERNATIONAL AB
Where to find product info
Recall notice and FDA enforcement page linked in the source URL
What timeline to expect
Refunds or replacements typically arise within weeks depending on manufacturer processing and regulatory actions
If the manufacturer is unresponsive
- Document all contacts with the manufacturer
- File a complaint with the appropriate regulatory body if the manufacturer is unresponsive
- Seek guidance from a healthcare provider on interim testing options
How to prevent similar issues
- Always verify PMA/510(k) clearance status before purchasing medical testing devices
- Ask providers to confirm device approval and batch details
- Monitor recall notices from FDA and the manufacturer for updates
Documentation advice
Keep the recall notice, device labels showing model numbers, purchase receipts, and all correspondence with the manufacturer or healthcare providers
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Product Details
Model numbers include EAN 616612787316 and SKU G670D. UDI-DI is None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Manufacturer: GET TESTED INTERNATIONAL AB. Recall date: 2025-11-03. Quantity recalled: 27 units. Status: ACTIVE. URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0795-2026. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 616612787316, SKU G670D
- Lot/Serial Number: All Lots
- Nationwide distribution in the US
- Regulatory issue: distribution without premarket approval/clearance
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Safety Guide
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